Inspiratory Muscle Training in Postmenopausal Women

NCT06459674 | Completed DMC FDA Device

• 1 other identifier: 20387
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted by the Department of Kinesiology within the School of Public Health at Indiana University Bloomington. The purpose of this study is to better understand how inspiratory muscle strength training affects cardiovascular health and mood disturbance in postmenopausal women.

Conditions

Postmenopausal Symptoms; Aging; Obesity

Keywords

postmenopausal; aging; women's health; blood pressure; mean response time; Inspiratory Muscle Training (IMT)

Outcome Measures

Primary Outcomes (1)

• Duration

  Duration, reported in seconds, to reach 63% of steady-state V̇O2 during a fixed-workload treadmill task. This technique is performed using breath-by-breath open-circuit spirometry and captures the V̇O2 fast component occurring in the transition from standing rest to treadmill walking.

  Baseline, within 48 hours of completing intervention

Secondary Outcomes (1)

• Distance Traveled

  Baseline, within 9 days of completing intervention

Other Outcomes (1)

• Cerebral Vascular Reactivity

  Baseline, within 9 days of completing intervention

Study Arms (2)

Inspiratory Muscle Training (IMT) group

EXPERIMENTAL

The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 4 times a week, and over 8-weeks.

Device: PrO2 Fit (IMT Trainer)

Sham Inspiratory Muscle Training (Sham-IMT) group

SHAM COMPARATOR

Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 4 times a week, and over 8-weeks.

Device: PrO2 Fit (IMT Trainer)

Interventions

PrO2 Fit (IMT Trainer) DEVICE

The device is used four times a week over a period of 8 weeks.

Inspiratory Muscle Training (IMT) group; Sham Inspiratory Muscle Training (Sham-IMT) group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women (self-report at least 6 years since last menstrual cycle)
• Aged 50-75 years (confirmed by birth date listed on participant's driver license at screening visit)
• English-speaking
• Body mass index between 25.0 to 39.9 kg/m2
• Able to ambulate without assistance
• Own or have access to a Bluetooth-capable phone or tablet (IOS version 12.0 or later or Android version 7.0 or later)

You may not qualify if:

• Unable to provide informed consent.
• Greater than stage II hypertension (i.e., \>159/99 mm Hg)
• Current tobacco use (self-report)
• Habitually exercise training ≥ 2 days per week (self-report)
• Significant orthopedic limitations or other contraindications to strenuous exercise
• Live or work \> 80 miles from Bloomington, Indiana
• Anticipated elective surgery during the study period.
• Surgery to the chest or abdomen in the last 6 months.
• Plan to move residence or travel out of the local area during the study period.
• History of heart attack or heart condition.
• Current use of prescription medications that affect heart rate or blood vessel dilation (e.g., systemic b-adrenergic blockers, calcium channel blockers, and hormone replacement therapy).
• Diagnosis of asthma or chronic pulmonary disease.
• Current respiratory infection.
• Diagnosis of an aneurysm in the chest, abdomen, or brain.
• Psychological or social characteristics that would interfere with their ability to fully participate in the study.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen J Carter, Ph.D

  Indiana University, Bloomington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All members of the research staff (i.e., those collecting data during experimental visits) will be blinded to the treatment group. The PI, who will not be part of data collection, will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 14, 2024
• Study Start: April 12, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)